跳至主要内容
临床试验/NCT04719351
NCT04719351已完成不适用

Diary of a Pandemic: The Use of a Mobile Application to Reduce Work-related Stress Symptoms Among Healthcare Workers

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2021年2月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
330
试验地点
1
主要终点
Emotional exhaustion delayed effect

研究概览

简要总结

The current pandemic highlighted an urgent need for early interventions to mitigate the psychological effects of extreme work demands that healthcare workers currently experience. This project aims at developing a data driven monitoring system to efficiently track work-related stress reactions over time. The system will also include a self-awareness intervention grounded on evidence-based strategies to improve workers' recovery. The solution will be delivered through a mobile application for a rapid implementation among healthcare workers and related professions. The mobile application will be developed through an initial analysis of pilot data, a factorial experiment and a user-experience analysis. Qualitative user experience data will also be used to validate the functionality of the monitoring system. The solution developed in this project will be easily scalable to related occupations, for example workers at elderly homes and social workers. After the pandemic, it can also be used as a preventive intervention for workers who are at risk of burnout and as a support for patients returning to work after treatment for common mental disorders.

详细描述

Symptoms indicating possibly pathological stress reactions among healthcare workers are more prevalent during the current pandemic than they were before. Possible reasons for that include higher levels of known risk factors such as cognitive, emotional, and physical demands at work; new stressors such as risk for moral injury and worry about personal safety; and diminished protective mechanisms, which include recovery opportunities and psychological detachment. Thus, frontline healthcare workers should be given priority in access to psychological support.

Despite the urgent need for it, a rapid implementation of psychological support for healthcare workers has proved to be challenging during previous crises and the current pandemic. Guidelines published thus far underline the necessity of close real-time monitoring in order to early identify at risk populations and individuals, who should be referred to seek professional support. However, appropriate tools for efficient real-time monitoring of stress responses and early screening for possibly pathological reactions among healthcare workers are currently lacking. Available tools focus either on tracking of stress indicators e.g. sleep disturbances, or on teaching strategies to better cope with stress e.g. mindfulness.

In this study, the investigators will test whether a separate use or a combination of these different functions may be the most efficient in managing work-related stress symptoms among healthcare workers. The study has a factorial design in order to closely investigate the functionalities focused on real-time monitoring of emotional responses and the functionalities based on evidence-based strategies to improve workers' recovery, as well as the possible interactions among them.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •adult participants
  • •working (active employment)

排除标准

  • •- no active employment e.g. sick leave, maternity leave during the entire period of an intervention (four weeks)

研究组 & 干预措施

Condition 1: Positive: no; Workload: no; Controllability: no; Open: no; Prompt: no;

Experimental

Component list:

  1. Questions about positive emotions: not included;
  2. Questions about workload/work environment: not included;
  3. Questions about controllability: not included;
  4. Questions with open answers: not included;
  5. Behavioral prompts: not included;

干预措施: The DIARY mobile application (Behavioral)

Condition 2: Positive: yes; Workload: no; Controllability: no; Open: no; Prompt: no;

Experimental

Component list:

  1. Questions about positive emotions: included;
  2. Questions about workload/work environment: not included;
  3. Questions about controllability: not included;
  4. Questions with open answers: not included;
  5. Behavioral prompts: not included;

干预措施: The DIARY mobile application (Behavioral)

Condition 3: Positive: no; Workload: yes; Controllability: no; Open: no; Prompt: no;

Experimental

Component list:

  1. Questions about positive emotions: not included;
  2. Questions about workload/work environment: included;
  3. Questions about controllability: not included;
  4. Questions with open answers: not included;
  5. Behavioral prompts: not included;

干预措施: The DIARY mobile application (Behavioral)

Condition 4: Positive: yes; Workload: yes; Controllability: no; Open: no; Prompt: no;

Experimental

Component list:

  1. Questions about positive emotions: included;
  2. Questions about workload/work environment: included;
  3. Questions about controllability: not included;
  4. Questions with open answers: not included;
  5. Behavioral prompts: not included;

干预措施: The DIARY mobile application (Behavioral)

Condition 5: Positive: no; Workload: no; Controllability: yes; Open: no; Prompt: no;

Experimental

Component list:

  1. Questions about positive emotions: not included;
  2. Questions about workload/work environment: not included;
  3. Questions about controllability: included;
  4. Questions with open answers: not included;
  5. Behavioral prompts: not included;

干预措施: The DIARY mobile application (Behavioral)

Condition 6: Positive: yes; Workload: no; Controllability: yes; Open: no; Prompt: no;

Experimental

Component list:

  1. Questions about positive emotions: included;
  2. Questions about workload/work environment: not included;
  3. Questions about controllability: included;
  4. Questions with open answers: not included;
  5. Behavioral prompts: not included;

干预措施: The DIARY mobile application (Behavioral)

Condition 7: Positive: no; Workload: yes; Controllability: yes; Open: no; Prompt: no;

Experimental

Component list:

  1. Questions about positive emotions: not included;
  2. Questions about workload/work environment: included;
  3. Questions about controllability: included;
  4. Questions with open answers: not included;
  5. Behavioral prompts: not included;

干预措施: The DIARY mobile application (Behavioral)

Condition 8: Positive: yes; Workload: yes; Controllability: yes; Open: no; Prompt: no;

Experimental

Component list:

  1. Questions about positive emotions: included;
  2. Questions about workload/work environment: included;
  3. Questions about controllability: included;
  4. Questions with open answers: not included;
  5. Behavioral prompts: not included;

干预措施: The DIARY mobile application (Behavioral)

Condition 9: Positive: no; Workload: no; Controllability: no; Open: yes; Prompt: no;

Experimental

Component list:

  1. Questions about positive emotions: not included;
  2. Questions about workload/work environment: not included;
  3. Questions about controllability: not included;
  4. Questions with open answers: included;
  5. Behavioral prompts: not included;

干预措施: The DIARY mobile application (Behavioral)

Condition 10: Positive: yes; Workload: no; Controllability: no; Open: yes; Prompt: no;

Experimental

Component list:

  1. Questions about positive emotions: included;
  2. Questions about workload/work environment: not included;
  3. Questions about controllability: not included;
  4. Questions with open answers: included;
  5. Behavioral prompts: not included;

干预措施: The DIARY mobile application (Behavioral)

Condition 11: Positive: no; Workload: yes; Controllability: no; Open: yes; Prompt: no;

Experimental

Component list:

  1. Questions about positive emotions: not included;
  2. Questions about workload/work environment: included;
  3. Questions about controllability: not included;
  4. Questions with open answers: included;
  5. Behavioral prompts: not included;

干预措施: The DIARY mobile application (Behavioral)

Condition 12: Positive: yes; Workload: yes; Controllability: no; Open: yes; Prompt: no;

Experimental

Component list:

  1. Questions about positive emotions: included;
  2. Questions about workload/work environment: included;
  3. Questions about controllability: not included;
  4. Questions with open answers: included;
  5. Behavioral prompts: not included;

干预措施: The DIARY mobile application (Behavioral)

Condition 13: Positive: no; Workload: no; Controllability: yes; Open: yes; Prompt: no;

Experimental

Component list:

  1. Questions about positive emotions: not included;
  2. Questions about workload/work environment: not included;
  3. Questions about controllability: included;
  4. Questions with open answers: included;
  5. Behavioral prompts: not included;

干预措施: The DIARY mobile application (Behavioral)

Condition 14: Positive: yes; Workload: no; Controllability: yes; Open: yes; Prompt: no;

Experimental

Component list:

  1. Questions about positive emotions: included;
  2. Questions about workload/work environment: not included;
  3. Questions about controllability: included;
  4. Questions with open answers: included;
  5. Behavioral prompts: not included;

干预措施: The DIARY mobile application (Behavioral)

Condition 15: Positive: no; Workload: yes; Controllability: yes; Open: yes; Prompt: no;

Experimental

Component list:

  1. Questions about positive emotions: not included;
  2. Questions about workload/work environment: included;
  3. Questions about controllability: included;
  4. Questions with open answers: included;
  5. Behavioral prompts: not included;

干预措施: The DIARY mobile application (Behavioral)

Condition 16: Positive: yes; Workload: yes; Controllability: yes; Open: yes; Prompt: no;

Experimental

Component list:

  1. Questions about positive emotions: included;
  2. Questions about workload/work environment: included;
  3. Questions about controllability: included;
  4. Questions with open answers: included;
  5. Behavioral prompts: not included;

干预措施: The DIARY mobile application (Behavioral)

Condition 17: Positive: no; Workload: no; Controllability: no; Open: no; Prompt: yes;

Experimental

Component list:

  1. Questions about positive emotions: not included;
  2. Questions about workload/work environment: not included;
  3. Questions about controllability: not included;
  4. Questions with open answers: not included;
  5. Behavioral prompts: included;

干预措施: The DIARY mobile application (Behavioral)

Condition 18: Positive: yes; Workload: no; Controllability: no; Open: no; Prompt: yes;

Experimental

Component list:

  1. Questions about positive emotions: included;
  2. Questions about workload/work environment: not included;
  3. Questions about controllability: not included;
  4. Questions with open answers: not included;
  5. Behavioral prompts: included;

干预措施: The DIARY mobile application (Behavioral)

Condition 19: Positive: no; Workload: yes; Controllability: no; Open: no; Prompt: yes;

Experimental

Component list:

  1. Questions about positive emotions: not included;
  2. Questions about workload/work environment: included;
  3. Questions about controllability: not included;
  4. Questions with open answers: not included;
  5. Behavioral prompts: included;

干预措施: The DIARY mobile application (Behavioral)

Condition 20: Positive: yes; Workload: yes; Controllability: no; Open: no; Prompt: yes;

Experimental

Component list:

  1. Questions about positive emotions: included;
  2. Questions about workload/work environment: included;
  3. Questions about controllability: not included;
  4. Questions with open answers: not included;
  5. Behavioral prompts: included;

干预措施: The DIARY mobile application (Behavioral)

Condition 21: Positive: no; Workload: no; Controllability: yes; Open: no; Prompt: yes;

Experimental

Component list:

  1. Questions about positive emotions: not included;
  2. Questions about workload/work environment: not included;
  3. Questions about controllability: included;
  4. Questions with open answers: not included;
  5. Behavioral prompts: included;

干预措施: The DIARY mobile application (Behavioral)

Condition 22: Positive: yes; Workload: no; Controllability: yes; Open: no; Prompt: yes;

Experimental

Component list:

  1. Questions about positive emotions: included;
  2. Questions about workload/work environment: not included;
  3. Questions about controllability: included;
  4. Questions with open answers: not included;
  5. Behavioral prompts: included;

干预措施: The DIARY mobile application (Behavioral)

Condition 23: Positive: no; Workload: yes; Controllability: yes; Open: no; Prompt: yes;

Experimental

Component list:

  1. Questions about positive emotions: not included;
  2. Questions about workload/work environment: included;
  3. Questions about controllability: included;
  4. Questions with open answers: not included;
  5. Behavioral prompts: included;

干预措施: The DIARY mobile application (Behavioral)

Condition 24: Positive: yes; Workload: yes; Controllability: yes; Open: no; Prompt: yes;

Experimental

Component list:

  1. Questions about positive emotions: included;
  2. Questions about workload/work environment: included;
  3. Questions about controllability: included;
  4. Questions with open answers: not included;
  5. Behavioral prompts: included;

干预措施: The DIARY mobile application (Behavioral)

Condition 25: Positive: no; Workload: no; Controllability: no; Open: yes; Prompt: yes;

Experimental

Component list:

  1. Questions about positive emotions: not included;
  2. Questions about workload/work environment: not included;
  3. Questions about controllability: not included;
  4. Questions with open answers: included;
  5. Behavioral prompts: included;

干预措施: The DIARY mobile application (Behavioral)

Condition 26: Positive: yes; Workload: no; Controllability: no; Open: yes; Prompt: yes;

Experimental

Component list:

  1. Questions about positive emotions: included;
  2. Questions about workload/work environment: not included;
  3. Questions about controllability: not included;
  4. Questions with open answers: included;
  5. Behavioral prompts: included;

干预措施: The DIARY mobile application (Behavioral)

Condition 27: Positive: no; Workload: yes; Controllability: no; Open: yes; Prompt: yes;

Experimental

Component list:

  1. Questions about positive emotions: not included;
  2. Questions about workload/work environment: included;
  3. Questions about controllability: not included;
  4. Questions with open answers: included;
  5. Behavioral prompts: included;

干预措施: The DIARY mobile application (Behavioral)

Condition 28: Positive: yes; Workload: yes; Controllability: no; Open: yes; Prompt: yes;

Experimental

Component list:

  1. Questions about positive emotions: included;
  2. Questions about workload/work environment: included;
  3. Questions about controllability: not included;
  4. Questions with open answers: included;
  5. Behavioral prompts: included;

干预措施: The DIARY mobile application (Behavioral)

Condition 29: Positive: no; Workload: no; Controllability: yes; Open: yes; Prompt: yes;

Experimental

Component list:

  1. Questions about positive emotions: not included;
  2. Questions about workload/work environment: not included;
  3. Questions about controllability: included;
  4. Questions with open answers: included;
  5. Behavioral prompts: included;

干预措施: The DIARY mobile application (Behavioral)

Condition 30: Positive: yes; Workload: no; Controllability: yes; Open: yes; Prompt: yes;

Experimental

Component list:

  1. Questions about positive emotions: included;
  2. Questions about workload/work environment: not included;
  3. Questions about controllability: included;
  4. Questions with open answers: included;
  5. Behavioral prompts: included;

干预措施: The DIARY mobile application (Behavioral)

Condition 31: Positive: no; Workload: yes; Controllability: yes; Open: yes; Prompt: yes;

Experimental

Component list:

  1. Questions about positive emotions: not included;
  2. Questions about workload/work environment: included;
  3. Questions about controllability: included;
  4. Questions with open answers: included;
  5. Behavioral prompts: included;

干预措施: The DIARY mobile application (Behavioral)

Condition 32: Positive: yes; Workload: yes; Controllability: yes; Open: yes; Prompt: yes;

Experimental

Component list:

  1. Questions about positive emotions: included;
  2. Questions about workload/work environment: included;
  3. Questions about controllability: included;
  4. Questions with open answers: included;
  5. Behavioral prompts: included;

干预措施: The DIARY mobile application (Behavioral)

结局指标

主要结局

Emotional exhaustion delayed effect

时间窗: A month after completed intervention

Emotional exhaustion is measured using Shirom-Melamed Burnout questionnaire (SMBQ), a 22-item instrument designed to assess burnout: Shirom, A., \& Melamed, S. (2006). A comparison of the construct validity of two burnout measures in two groups of professionals. International journal of stress management, 13(2), 176. This study uses the SMBQ-6, a subset of six items, specifically measuring emotional exhaustion. A Swedish version is used for this study: Lundgren-Nilsson, Å., Jonsdottir, I. H., Pallant, J., \& Ahlborg, G. (2012). Internal construct validity of the Shirom-Melamed Burnout questionnaire (SMBQ). BMC public health, 12(1), 1. Items are scored on a 7-point Likert scale (1 = Very rarely, 7 = Very frequently).

Emotional exhaustion immediate effect

时间窗: Immediately post-intervention

Emotional exhaustion is measured using Shirom-Melamed Burnout questionnaire (SMBQ), a 22-item instrument designed to assess burnout: Shirom, A., \& Melamed, S. (2006). A comparison of the construct validity of two burnout measures in two groups of professionals. International journal of stress management, 13(2), 176. This study uses the SMBQ-6, a subset of six items, specifically measuring emotional exhaustion. A Swedish version is used for this study: Lundgren-Nilsson, Å., Jonsdottir, I. H., Pallant, J., \& Ahlborg, G. (2012). Internal construct validity of the Shirom-Melamed Burnout questionnaire (SMBQ). BMC public health, 12(1), 1. Items are scored on a 7-point Likert scale (1 = Very rarely, 7 = Very frequently).

Stress symptoms immediate effect

时间窗: Immediately post-intervention

Stress is measured using the Perceived Stress Scale (PSS), designed to measure "the degree to which situations in one´s life are appraised as stressful" (Cohen, S., Kamarck, T., \& Mermelstein, R. \[1983\]. A global measure of perceived stress. Journal of health and social behavior, 385-396). The original scale contains 14 items, and this study uses the PSS-10 version which contains 10 items. A Swedish translation of the scale is used: Nordin, M., \& Nordin, S. (2013). Psychometric evaluation and normative data of the Swedish version of the 10-item perceived stress scale. Scandinavian journal of psychology, 54(6), 502-507. The items are scored on a 5-point Likert scale (1 = Never, 5 = Very often).

Burnout symptoms immediate effect

时间窗: Immediately post-intervention

Burnout is measured using Oldenburg Burnout Inventory (Olbi), an instrument designed to measure exhaustion and disengagement: (Demerouti, E, Bakker, A.B, Vardakou, I, \& Kantas, A. \[2003\]. The convergent validity of two burnout instruments : a multitrait-multimethod analysis. European Journal of Psychological Assessment : Official Organ of the European Association of Psychological Assessment, 19(1), 12-23. https://doi.org/10.1027//1015-5759.19.1.12) The full Olbi scale consists of twelve items, and this study uses a subset of seven items. The study uses a Swedish version: Gustavsson, J. P., Hallsten, L., \& Rudman, A. (2010). Early career burnout among nurses: modelling a hypothesized process using an item response approach. International Journal of Nursing Studies, 47(7), 864-875. The items are scored on a 4-point Likert scale (1 = Not at all, 4 = Exactly).

Burnout symptoms delayed effect

时间窗: A month after completed intervention

Burnout is measured using Oldenburg Burnout Inventory (Olbi), an instrument designed to measure exhaustion and disengagement: (Demerouti, E, Bakker, A.B, Vardakou, I, \& Kantas, A. \[2003\]. The convergent validity of two burnout instruments : a multitrait-multimethod analysis. European Journal of Psychological Assessment : Official Organ of the European Association of Psychological Assessment, 19(1), 12-23. https://doi.org/10.1027//1015-5759.19.1.12) The full Olbi scale consists of twelve items, and this study uses a subset of seven items. The study uses a Swedish version: Gustavsson, J. P., Hallsten, L., \& Rudman, A. (2010). Early career burnout among nurses: modelling a hypothesized process using an item response approach. International Journal of Nursing Studies, 47(7), 864-875. The items are scored on a 4-point Likert scale (1 = Not at all, 4 = Exactly).

Stress symptoms delayed effect

时间窗: A month after completed intervention

Stress is measured using the Perceived Stress Scale (PSS), designed to measure "the degree to which situations in one´s life are appraised as stressful" (Cohen, S., Kamarck, T., \& Mermelstein, R. \[1983\]. A global measure of perceived stress. Journal of health and social behavior, 385-396). The original scale contains 14 items, and this study uses the PSS-10 version which contains 10 items. A Swedish translation of the scale is used: Nordin, M., \& Nordin, S. (2013). Psychometric evaluation and normative data of the Swedish version of the 10-item perceived stress scale. Scandinavian journal of psychology, 54(6), 502-507. The items are scored on a 5-point Likert scale (1 = Never, 5 = Very often).

次要结局

  • Post-traumatic stress immediate effect(Immediately post-intervention)
  • Controllability delayed effect(A month after completed intervention)
  • Social support immediate effect(Immediately post-intervention)
  • Anxiety symptoms immediate effect(Immediately post-intervention)
  • Emotional awareness delayed effect(A month after completed intervention)
  • Depressive symptoms delayed effect(A month after completed intervention)
  • Recovery experience immediate effect(Immediately post-intervention)
  • Anxiety symptoms delayed effect(A month after completed intervention)
  • Depressive symptoms immediate effect(Immediately post-intervention)
  • Post-traumatic stress delayed effect(A month after completed intervention)
  • Emotional awareness immediate effect(Immediately post-intervention)
  • Controllability immediate effect(Immediately post-intervention)
  • Recovery experience delayed effect(A month after completed intervention)
  • Social support delayed effect(A month after completed intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleksandra Sjöström-Bujacz

Project Leader

Karolinska Institutet

研究点 (1)

Loading locations...

相似试验